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AnesthesiaNCT06074471

Motor Sparing Supraclavicular Block

A study testing ultrasound guided supraclavicular brachial plexus block in people with Anesthesia and Regional Anesthesia Morbidity, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to compare MS-SCBPB and SCBPB in the duration of postoperative analgesia, time to first analgesic request (VAS ≥40 mm), pain scores, motor power, and side effects. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Anesthesia, Regional Anesthesia Morbidity
What is being tested?
ultrasound guided supraclavicular brachial plexus block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteEgypt
Study dates
25 Sep 2023to May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients scheduled for upper limb surgeries under supraclavicular brachial plexus block
  • American Society of Anesthesiologists (ASA) status I and III
  • between ages of 18 and 60 years

Who cannot join

  • Bleeding disorders with INR > 1.5 and/or platelets < 100,000/mm3
  • infection at the injection site
  • Allergy to local anesthetics
  • Severe cardiopulmonary disease (≥ASA IV)
  • Diabetic or other neuropathies
  • Motor disorders
  • Patients receiving opioids for chronic analgesic therapy
  • Inability to comprehend visual analogue scale (VAS).

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Cairo university Hospitals. kasralainy

    Cairo, Governorate, 002

    Nagy malak, 01552480258, nagymalak789@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: Motor Sparing Supraclavicular Brachial Plexus Block (MS-SCBPB): A Randomized Controlled Trial

This study aims to compare MS-SCBPB and SCBPB in the duration of postoperative analgesia, time to first analgesic request (VAS ≥40 mm), pain scores, motor power, and side effects.

Read the detailed description

On arrival of the patients to regional anesthesia room, patients will be secured with 20-gauge intravenous cannula. Monitoring will include ECG, non-invasive arterial blood pressure, and pulse oximetry (SpO2).

Before receiving supraclavicular brachial plexus block, patients will be randomly assigned into one of the two study groups:

MS-SCBPB Group (n=22): this group will receive ultrasound-guided supraclavicular brachial plexus block with total volume 20 mL bupivacaine 0.20% and 8 mg dexamethasone.

SCBPB Group (n=22): this group will receive ultrasound-guided supraclavicular brachial plexus block with total volume 20 mL bupivacaine 0.5% and 8 mg dexamethasone.

Another doctor not involved in the block procedure will evaluate the patients postoperative.

Technique of SCBPB:

The technique of ultrasound-guided supraclavicular brachial plexus block will be performed with the patient in semi-sitting position with head tilted to the opposite side of injection site. A linear ultrasound probe (4-12MHz) will be placed parallel to the clavicle in the supraclavicular fossa visualizing the subclavian artery is seen beating above the first rib. A volume of 2 mL lignocaine 2% will be infiltrated subcutaneous before the block. A 20-gauge needle will be advanced in plane under direct vision aiming to the corner pocket towards the deeper portion of the brachial plexus at the angle between the first rib and the subclavian artery, a total of 10 mL of drug will be injected, aspirating every 5 ml. Then, the needle will be retracted and advanced at a shallower angle, aiming toward the superficial brachial plexus after negative aspiration, 10 mL of drug will be injected, aspirating every 5 ml.

Block assessment:

Time needed for surgical block: the time interval from the end of ultrasound guided supraclavicular brachial plexus block injection till achievement surgical anesthesia

Assessment of surgical anesthesia using a 3-point score:

Extent of sensory block:

In all four nerves: hypothenar eminence (ulnar nerve), thenar eminence (median nerve), dorsum of hand (radial nerve), and lateral aspect of the forearm (musculocutaneous nerve) 0 = loss of sensation to light touch, 1 = loss of sensation to pinprick, 2 = normal sensation

Extent of motor block:

In all four nerves: thumb adduction (ulnar nerve), thumb opposition (median nerve), thumb abduction (radial nerve), and flexion of the elbow in supination and pronation (musculocutaneous nerve) 0 = no movement, 1 = paresis, 2 = normal movement Interpretation : Block success for surgical anesthesia is defined as the achievement of sensory and or motor scores of 1 or less at 5, 10, 15, 20, and 30 minutes post-injection.

Intraoperative Care:

An anesthesiologist blinded to group allocation will be attending for monitored anesthesia care with a safe conscious sedation intraoperatively, titrated to patient comfort using low intravenous doses of midazolam (1-3mg), fentanyl (1-2 μg/kg), and/or Propofol (25-75 μg/kg/min). In the event of failed block, it will be managed with either local anesthetic supplementation at the corresponding spared nerve or converted to general anesthesia.

Postoperatively, all patients will receive 1 g paracetamol every 6 h and 30 mg ketorolac every 12 h. Intravenous morphine titration will be carried out at patient wake-up to achieve pain control (Using visual analogue scale (VAS) for pain assessment from 0 the Best to 10 the worst) by an attending anesthesiologist blinded to group allocation. Patients with a VAS score of ≥ 4 and patients who will request rescue analgesia will be treated with IV morphine in 2 mg increments every 4 hours with upper limit for the total administered dose (maximum 20 mg per day). If the patient appeared sedated (Ramsay sedation scale > 2), and/or severe morphine-related side effects are encountered including respiratory depression (Spo2 < 95% and/or RR < 12 breaths/min), allergic reaction, hypotension, or severe pruritus, morphine titration will be stopped and the patient will be excluded from the study.

Being tested
ultrasound guided supraclavicular brachial plexus block
Keywords
Motor sparing, SCBP block, Upper limb operations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ultrasound guided supraclavicular brachial plexus blockProcedure or surgery

    Also called Drugs used (bupivacaine and dexamethazone)

    Block will be performed in semi-sitting position with head tilted to the opposite side of injection site. linear probe (4-12MHz) (Mindray Digital Ultrasonic Model DP-10 "SN 6N-49005130" 2014-09. SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.LTD) will be placed parallel to the clavicle in the supraclavicular fossa visualizing the subclavian artery is seen beating above the first rib. A volume of 2 mL lignocaine 2% will be infiltrated subcutaneous before the block. A 20-gauge needle will be advanced in plane aiming to the corner pocket towards the deeper portion of the brachial plexus at the angle between the first rib and the subclavian artery, 10 mL of drug will be injected. Then, the needle will be retracted and advanced at a shallower angle, aiming toward the superficial plexus after negative aspiration another 10 ml will be injected, total drug injected 20 ml (18 mL of drug will be injected with addition to 8mg dexamethasone (2ml))

Study groups in NCT06074471
Study groupRoleWhat they receive
MS-SCBPB Group (n=22)Experimentalreceive ultrasound-guided supraclavicular brachial plexus block with total volume 20 mL bupivacaine (concentration 0.20%) "9 ml Bupivacaine+9ml lignocaine +2ml Dexamethasone 8mg "
Receives: Procedure: ultrasound guided supraclavicular brachial plexus block
SCBPB Group (n=22):Active comparatorreceive ultrasound-guided supraclavicular brachial plexus block with total volume 20 mL bupivacaine (concentration 0.5%) "18 ml Bupivacaine+2ml Dexamethasone 8mg"
Receives: Procedure: ultrasound guided supraclavicular brachial plexus block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of motor blockade

    Duration of motor blockade

    Measured: 24 hours

Secondary outcomes (5)
  1. Time needed for surgical block:

    the time interval between the injection of the study medication till surgical anesthesia.

    Measured: 24 hours

  2. Time needed for complete recovery from sensory and motor block at 2, 4, 6, 12, 18, and 24 hours postoperatively.

    Time needed for complete recovery from sensory and motor block at 2, 4, 6, 12, 18, and 24 hours postoperatively.

    Measured: 24 hours

  3. Time to first analgesic request

    Time to first analgesic request Using Visual analogue scale (VAS) for pain assessment from 0 the Best to 10 the worst) ...rescue analgesic given if VAS >4

    Measured: 24 hours

  4. Visual analogue scale (VAS)

    Visual analogue pain score for pain assessment from 0 the Best to 10 the worst) at 2, 4, 6, 12, 18, and 24 hours postoperatively.

    Measured: 24 hours

  5. Total morphine requirements

    Total morphine requirements 24 hours postoperatively.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start25 Sep 2023
  3. Primary completionMay 2024 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Drugs used (bupivacaine-lidocaine-Dexamethazone) Rescue analgesic is morphine
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06074471
Sponsor's protocol ID
N-267-2023
Status last verified
May 2024
First submitted
25 Sep 2023
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ultrasound guided supraclavicular brachial plexus block in people with Anesthesia and Regional Anesthesia Morbidity, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nagy malak, MD (01552480258, nagymalak@kasralainy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of motor blockade (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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